Regulatory Affairs Manager: CMC & Global Submissions Lead

Amgen; Breda; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Best PlaceToWork

Health insurance

On-site gym

Restaurant on-site

Fixed 13th month

Holiday allowance

Job summary

Amgen Breda is seeking a Regulatory Affairs Manager to lead site CMC regulatory activities for global submissions and post-market changes. You will collaborate with cross-functional teams and regulatory authorities to plan and execute site-specific regulatory strategies.

The ideal candidate holds a Doctorate or Master’s degree (or a Bachelor’s with extensive RA experience) and demonstrates strong leadership, English and Dutch communication, and project-management skills in a fast-paced biotech

Qualifications

• Doctorate or Master’s degree with 3+ years RA/QA experience in pharma/biotech, or a Bachelor’s with 5+ years RA/QA experience.
• Background in Biology, Biotechnology, Microbiology or Chemistry.
• Experience managing change control and regulatory submissions.

Responsibilities

• Translate CMC regulatory requirements into practical plans for site-specific submissions.
• Lead site initiatives and regulatory submissions for new marketing applications and post-market changes.
• Act as RA-CMC representative on cross-functional teams and liaise with authorities.

Skills

Leadership

Regulatory affairs

Project management

Communication (EN/Dutch)

Education

Doctorate or Master’s degree

Bachelor’s degree

Job description

Amgen Breda is seeking a Regulatory Affairs Manager to lead site CMC regulatory activities for global submissions and post-market changes. You will collaborate with cross-functional teams and regulatory authorities to plan and execute site-specific regulatory strategies.

The ideal candidate holds a Doctorate or Master’s degree (or a Bachelor’s with extensive RA experience) and demonstrates strong leadership, English and Dutch communication, and project-management skills in a fast-paced biotech